JP2012509125A - Improved airway device. - Google Patents

Abstract

An airway device for animal and human use, the airway device comprising an airway tube having a distal end and a proximal end. Here, the distal end of the airway tube is surrounded by a non-inflatable laryngeal cuff, where the surface of the laryngeal cuff is shaped so as to be biocompatible with the laryngeal opening of the animal or human patient, The surface of the laryngeal cuff is usually elongated and substantially oval in shape, where the ratio A / B of the length of the major axis A of the ellipse to the length of the minor axis B of the ellipse is greater than 2 ± 10% is there.
[Selected figure] Figure 1

Description

  The present invention relates to medical devices, and is particularly applicable to, but not limited to, laryngeal airway devices and methods of their manufacture. The present invention relates to a simple but versatile, improved airway device for use in anatomy. It is a device especially used in the administration of oxygen and anesthetic gases to human and animal patients breathing spontaneously or intermittently for positive pressure ventilation (IPPV) during surgery or resuscitation. But not limited to.

  A wide variety of devices are known, either during spontaneous breathing or for intermittent positive pressure ventilation of anesthetized patients during recovery after anesthesia or after intensive care, or It is currently used to provide a clean, hands-free airway during resuscitation. A number of these devices are listed in the applicant's earlier patent, namely GB Patent GB 2 393 399 B, the text of which is incorporated herein by reference, which is incorporated by reference into the present disclosure. It is intended to form a part. UK Patent No. GB 2, 393, 399 B describes a new type of airway device with a soft laryngeal cuff which is adapted to be anatomically adapted to the patient's laryngeal structure to form a seal.

  The laryngeal cuffs of these devices are usually made of a soft, deformable material that is non-inflatable but can be adapted to the individual details of the patient's laryngeal to form a satisfactory seal .

  These new laryngeal airway devices using non-inflatable cuffs have been found to provide significant improvements in safety and reliability. While they provide adequate inflation and sealing pressure to the vapor, they cause little trauma to the underlying structures of the patient's laryngopharynx.

  In the case of administering anesthesia to animals, particularly small animals such as dogs, cats, rabbits, etc., devices having expandable laryngeal cuffs are usually not convenient for the user or the patient. The problem arises because the epiglottis of such animal or young human children is much longer and more flexible than the epiglottis of an adult human subject, and as a result, the epiglottis bends Because it tends to block the exhaust of the airway conduit inside the cuff, it may block or block the flow of anesthetic gas. Also, because the expandable portion of the expandable device is close to the oral cavity, this will cause holes to be drilled over the teeth during insertion, resulting in a lack of sealing of the resulting pharynx or larynx, or During removal, there is always the danger that the expensive and reusable general steel for polished bars (SGD) can not be used.

  As a result, it is more standard to use endotracheal tubes either inflated or not inflated when anesthetizing animals or small children. Endotracheal tubes have their own unique problems and drawbacks, especially under inadequate local level or under the lower limit level of general anesthesia.

  In cats, laryngeal spasms, cough, upset, breathlessness, or bronchospasm can occur during intubation. A laryngeal tracheal injury or tear from a wide diameter or cuffed endotracheal tube has also been reported. The rabbit has a narrow pharyngeal inlet, a small larynx, and a minimal view of the hypopharynx and larynx in oral examination. This makes rabbits very difficult to intubate and, if it can, usually only small endotracheal tubes can be used. Repeated blind intubation attempts may cause laryngeal tracheal edema, which may then cause airway obstruction with extubation.

  Endotracheal intubation uses short- or long-acting muscle-relaxing material as part of an anesthesia technique to temporarily paralyze the vocal cords to safely and easily pass the endotracheal tube wide open vocal cords I need. However, in small pets, muscle relaxants are used infrequently because of repeated laryngoscopy attempts or the risk of airway failure or loss during intubation. Thus, in the absence of muscle relaxants, endotracheal intubation is even more difficult and can cause trauma. During insertion of the endotracheal tube into animals and humans, the device must pass through the vocal cords, which can cause damage to these vocal cords. This damage may not disappear for the rest of your life. If a non-distensible tube is used then it is important that the tube fit snugly in the trachea. The degree of sealing around the tube is highly dependent on the anesthesiologist's choice of the proper diameter tube. Intubation of small animals usually requires multiple attempts to achieve intubation successfully, even in experienced and skilled personnel. This results in damage to the basic structure of the vulnerable throat, which in turn causes swelling of the larynx and airway obstruction with edema and extubation, which will often be fatal in small animals. Favorable conditions for successful intubation, ie, relaxed vocal cords and laryngeal, laryngoscope and intubation responses, utilization of excessive amounts of anesthetic to achieve laryngeal tracheal stimulation, to soft tissue, teeth, or cartilage Trauma, extubation reaction, laryngeal bronchial spasm, cough, hemorrhage, dysphagia, dysphoria, sore throat and infection, patient discomfort, mucosal discomfort, perforation of pharyngeal esophagus, pneumothorax, subcutaneous emphysema, posterior pharyngeal abscess, mediastinitis, This can result in dislocation and vocal cord damage in tracheoesophageal fistula, arytenoid cartilage and small angle cartilage.

  Expandable supraglottic airway devices are commonly used in human anesthesia, but because they are specifically designed for human use, they have rarely been used in veterinary anesthesia practice.

  The supraglottic airway system, designed for veterinarians, is particularly important for anesthesia for small pets and may provide an improvement for human use.

  Accordingly, it is an object of the present invention to solve or alleviate some or all of these problems, and to provide an improved airway device for both animal and human use.

British Patent No. 2,393,399 B

  Claim 1 of the present invention describes an airway device. A first embodiment provides an airway device for animal or human use, the device comprising an airway tube having a proximal end and a distal end, wherein the distal end of the airway tube is the larynx Surrounded by cuffs. And here, the surface of the laryngeal cuff is adapted to the laryngeal opening of the animal or human patient and is shaped to create a seal at the patient's laryngeal opening. Here, the surface of the laryngeal cuff is usually elongated and substantially elliptical in shape, wherein the ratio A / B of the major axis A of the ellipse to the minor axis B of the ellipse is at least about 2 .0 ± 10%.

The surface of the cuff forms a considerable fluid tight seal in the area around the patient's laryngeal opening during use. A significant fluid seal in this context means a seal that may include pressures equivalent to up to 30 cm H ₂ O.

  The distal end of the airway tube is surrounded by a laryngeal cuff, and necessarily there is an opening in the surface of the cuff in fluid communication with the airway tube. By forming the opening on the surface of the cuff, in particular the surface of the cuff, as an elongated oval, this allows the epiglottis to cover part of the opening without disturbing the airway tube.

  In calculating the ratio A / B, the length of the long axis of the cuff surface is taken as the distance between the distal tip of the device and the proximal end of the epiglottis rest closest to the end of the device connector. The length of the short axis of the surface of the cuff is taken as the width of the cuff at its widest point.

  A further preferred value for the ratio A / B is greater than 2.3 ± 10%.

  In a particularly preferred embodiment, the ratio A / B is greater than 2.5 ± 10% and it is further preferred that the ratio A / B is 2.6 ± 10%.

  Preferably, the shape of the surface of the cuff is substantially elliptical, but the shape of the openings in the surface of the cuff is non-elliptic.

  The laryngeal cuff is a three-dimensional item. So it has a depth between the back, front, and between front and back, but the depth can vary over the area of the cuff. The front of the cuff includes an opening that may be considered as a dilation of the airway tube. The openings in the surface of the cuff are perfectly smaller inside the cuff surface, so that in their contours they are necessarily smaller than the outer contour of the cuff surface itself. The shape and contour of the opening in the surface of the cuff are different from the shape and contour of the surface of the cuff. Thus, for example, in some of the embodiments described herein, the shape of the surface of the cuff may be normal or substantially elliptical, but the shape of the surface of the cuff may be non-elliptic.

  It is also understood that the cuff of such a device must be contoured smoothly in the area outside the cuff to minimize the risk of causing any damage to sensitive tissue in the patient's laryngopharyngeal area It will Therefore, the front, back and sides of the laryngeal cuff will assimilate with each other smoothly, and the cuff itself will assimilate into the airway tract and stabilizer area of the oral cavity. To that end, the back and front of the cuff join smoothly with each other rather than having a clear demarcation line between the two.

  Preferably, the width of the opening at the proximal end of the surface of the cuff is narrower than the width of the opening at the distal end of the airway cuff.

  This feature bends the opening of the epiglottis by narrowing the opening at the surface of the upper cuff area, which is the area of the proximal end of the cuff, in the portion of the cuff where the epiglottis is likely to settle during use It greatly reduces the possibility of blocking the department and thereby limiting the airway. This is particularly true if the feature is used in conjunction with the raised portion at the proximal end of the cuff or a combination of elongated elliptical cuff surfaces. This substantially creates a cut or an elongated opening in the upper region of the cuff. Although this incision is approximately equal to or longer than the normal length of the epiglottis, the width of the incision is narrower than that of the epiglottis or the epiglottis to prevent bending to the distal end opening of the airway conduit of the epiglottis Even if it bends, it still can not block the airway.

  Preferably, the surface of the laryngeal cuff is such that the opening at the end of the airway tube is substantially avoided, so as to prevent the patient's epiglottis from blocking the opening at the distal end of the airway tube during use. By holding, the size, shape and position are set and the epiglottis support or rest is incorporated. The support of the epiglottis may be in the form of a narrowing of the opening on the surface of the cuff, or in other forms or in both forms.

  On the one hand, the laryngeal cuff may be considered as a dilation of the airway tube. On the other hand, the airway can be considered borderline as it enters the laryngeal cuff. In any event, it is important that the airway tube not be blocked during use. If something covers substantially all of the openings on the surface of the laryngeal cuff, or if something covers or blocks the airway tube or the end of the airway tube where it enters the laryngeal cuff, airway tube obstruction occurs. obtain. The patient's epiglottis can potentially cause occlusion in both of these ways. Here, the epiglottis support described and defined, in one or more of its various shapes, can prevent such occlusion.

  The airway tube usually has a height H and a width W, preferably the epiglottis support comprises an area of the cuff or airway tube projecting above the usual height H of the contour of the airway tube.

  Preferably, the narrow area of the opening on the surface of the cuff may correspond to the area of support of the epiglottis and provide support for the epiglottis itself.

  Preferably, the opening of the airway tube at the proximal end of the laryngeal cuff is substantially V-shaped and the narrow portion of the V-shaped opening is the distal end of the airway tube of the patient during use Act as a rest of the epiglottis to prevent blocking.

  As previously unknown, this causes the epiglottis, which should be bent, to block the airway tube by shaping the proximal end of the opening on the surface of the laryngeal cuff into a V-shape Used to prevent.

  Thus, it can be seen that the elongate opening in the surface of the elongate laryngeal cuff described above has the opposite side of the opening. The sides are brought together in several ways at the proximal and distal ends of the openings. In embodiments of the present invention, the opposite side of the opening at the proximal portion of the opening creates a narrow area covering 25 ± 10% of the length of the opening along the longitudinal axis of the device. While this narrowing may be accomplished by matching the opposite side to a V-shape, this is not the only shape that can produce a favorable effect. A narrow U-shaped area at the proximal end of the opening also has a favorable effect.

  The narrow area is usually an area where the width at the widest point in the narrow area is less than 50% of the opening in the cuff surface at the widest point. Thus, while a V-shape or a narrow U-shape is convenient, the exact shape of the opening is not important.

  Preferably, the angle made between the two branches of "V" is approximately 10 degrees to 50 degrees, more preferably approximately 20 degrees to 40 degrees, and in a particularly preferred embodiment approximately It is 30 ± 5 degrees.

  Preferably, the main plane of the surface of the laryngeal cuff is at an angle between 10 degrees and 40 ± 5 degrees with respect to the main longitudinal axis of the airway tube, more preferably the surface of the cuff and the main longitudinal axis of the airway tube The angle between is between 15 degrees and 25 ± 5 degrees. By designing the surface of the cuff so that the angle between the surface of the cuff and the main longitudinal axis of the airway tube is at these angles, the epiglottis will be farther away from the opening at the surface of the cuff.

  Preferably, the surface of the laryngeal cuff is made of a material of Shore A hardness of 40 or less, and more preferably of a material of Shore hardness of A scale between 000 and 20.

  In a particularly preferred embodiment, the airway tube and laryngeal cuff are made of a material having a Shore hardness of A scale of 40 or less, and more preferably, the airway tube and laryngeal cuff have a Shore hardness of 30 ± 10 A scale Made from materials.

  In another preferred embodiment, the airway tube and laryngeal cuff are made of a material having an A scale with a Shore hardness of 60 or less, more preferably, the Shore hardness is 40 or less. Of importance from the patient's point of view is the perceived softness rather than the inherent hardness or softness of the material from the device, in particular from the surface of the device's cuff in contact with the patient. While this gives the impression that the Shore hardness is less than 40, it also allows materials having a Shore hardness of 40 to 70 A scale to be used satisfactorily.

  In a further particularly preferred embodiment applicable to all aspects of the invention, the surface of the laryngeal cuff, which is the part of the cuff in contact with the patient in use, is made of a first material having one Shore hardness, And the rest of the device body is made of a second material having different Shore hardness. As used herein, the remainder of the device body excludes the connection, but may include the rest or back portion of the laryngeal cuff, airway tube and oral stabilizer.

  Preferably, the surface of the laryngeal cuff is made of a first material having an A scale Shore hardness of 20 or less, and more preferably 15 or less. More preferably, the surface of the laryngeal cuff is made of a first material having a Shore hardness of A to 1000 000.

  The airway tube, the oral stabilizer, if any, and the back of the laryngeal cuff are made of a material having an A-scale Shore hardness of less than 60, and preferably less than 50. More preferably, the airway tube, the oral stabilizer and the back of the laryngeal cuff are made of a material having an A scale Shore hardness in the range of 20 to 40.

  Both the cuff and the outer part of the airway tube in contact with the patient comprise a plastic material, preferably a potential rubber material, and a thermoplastic resin material or a crosslinked (thermosetting resin) material having substantially the same Shore hardness Made from The connection connects the device to the supply of anesthetic gas. This connection extends into the airway tube as a tube lining and bite protection. Thus, the connection serves to increase the rigidity of the device, where the connection is made of a relatively hard material which is not folded. The connection not only acts as a connection, but is integrated in such a way as to provide the desired rigidity at the same time as the function of bite prevention and to provide internal support to the device. In addition, the outer surface of the airway tube may incorporate external ridges. These ridges, in a preferred embodiment, are attached or taped to the patient, particularly to an animal patient whose face is covered with hair or fur, to the patient, in particular It is useful when The ridges may also be located along the outside of the airway and in any suitable location.

  In a particularly preferred embodiment, the entire apparatus is made of substantially the same, A-scale Shore hardness material, except at the connection. The preferred Shore hardness is 60 or less, and the particularly preferred Shore hardness is 40 or less. The perceived softness of the device may be altered, for example, by a honeycomb structure, by incorporating grooves or cavities within the device body in addition to the airway tube. Alternatively, the thickness of the various cross sections may be reduced. In both situations, the airway device feels softer than what the Shore hardness of the assembled material indicates. Therefore, what is important from the patient's point of view is the perceived softness rather than the inherent hardness or softness of the material from the device, in particular from the surface of the device's cuff in contact with the patient. While this gives the impression that the Shore hardness is less than 40, it allows materials with a Shore hardness of 40 to 70 A scale to be used satisfactorily.

  Preferably, the airway device further comprises an oral stabilizer, said oral stabilizer being adapted to rest on the front or front of the patient's tongue, likely to be even further towards the bottom of the tongue, corresponding to the details of that part of the patient To provide stability by blocking the rotational or lateral movement of the airway tube during use.

  Preferably, the softness of the laryngeal cuff is accommodated by forming a cavity or groove in the cuff body itself. This allows the device to be made of a stiffer, stiffer, plastic material but still provide favorable softness in the area of the cuff.

  Preferably, the surface of the laryngeal cuff and the anterior and ventral surface portions of the oral stabilizer are made of a material of substantially the same Shore hardness. This can simplify the structure and make all parts in contact with the patient's soft tissue relatively soft.

  Preferably, the oral stabilizer has a first ventral surface substantially in the same plane as the plane of the opening of the laryngeal cuff.

  Preferably, the oral stabilizer extends from the proximal end of the laryngeal cuff towards the proximal end of the airway tube so that the cuff and oral stabilizer are unitary, and preferably the laryngeal cuff, the support of the epiglottis, (if The oral stabilizer, if any, and the airway tube are made as an integrated unit during manufacture.

  Preferably, the oral stabilizer is not uniform in width W and has a wide point located midway between the laryngeal cuff and the proximal end of the airway tube, and preferably the wide point of the oral stabilizer is the airway tube Is closer to the laryngeal cuff than to the proximal end of the.

  Preferably, the ratio of the width W of the oral stabilizer at its widest point to the height H of the oral stabilizer at that same point is between 2 and 3 ± 20%, more preferably 2.5 to 2. Between 7 ± 20%.

  Preferably, the surface of the oral stabilizer in contact with the patient's tongue is roughened by increasing the friction between the tongue and the stabilizer during use.

  Preferably, the oral stabilizer is formed as an integral part of the airway tube.

  Preferably, the oral stabilizer is non-distensible.

  Preferably, the device includes a gastric tube passageway extending from the tip of the cuff to the proximal end of the device, and preferably, the gastric tube passageway is housed within the device body.

  Preferably, the gastric tube passageway extends along the airway tube.

  Preferably, the gastric tube passageway continues from the opening at the proximal end of the device to the opening at the distal tip of the laryngeal cuff.

  Preferably, the epiglottis rest further comprises a leaf-like structure extending away from the laryngeal cuff back towards the proximal end of the device (end of the connection).

  Preferably, the laryngeal cuff further comprises one or more feather-like prongs. These tongues improve the quality of the seal between the surface of the device and the patient's laryngeal opening.

Preferably, the distal tip of the device is sized and shaped to create an esophageal obstruction, blocking the opening to the subject's esophagus during use by creating a substantial fluid seal therein . By extending the length of A or the long axis of the substantially oval shaped cuff, the distal tip of the cuff extends into the subject's esophagus, and partially into the subject's esophagus It may be designed to reach. The distal tip volume may be designed to occlude the subject's esophagus during use.

  As such, the distal tip of the device is preferably formed as a wide extension of the laryngeal cuff to a generally elongated substantially oval surface. This causes the shape of the laryngeal cuff to deviate from the true ellipse.

  Preferably, the dorsal or posterior surface of the laryngeal cuff includes one or more ridges, which are sized and shaped so that they contact the back of the subject's throat during use Ru. This serves to hold the device against the laryngeal opening by including, in use, a raised area behind the cuff that contacts the structure opposite the laryngeal opening of the subject, and therefore Create a gentle force that improves the seal between the two.

  Preferably, the ridges are in the form of a soft, raised cushion. The raised area is preferably behind the proximal portion of the opening on the surface of the cuff.

  In a further preferred embodiment, the front, ventral portion of the cuff may be inflatable. The expandable laryngeal cuff itself is known but does not have the particular shape and properties described herein. The inflatable cuff on the front of the laryngeal cuff is used with or without an inflatable back cuff or cushion. The choice is made, in part, depending on which animal the particular device is intended to be used.

  According to a further aspect of the present invention there is provided an airway device for animal or human use, said device comprising an airway tube having a distal end and a proximal end, wherein the distal portion of the airway tube is remote. The lateral end is surrounded by a laryngeal cuff, and the surface of the laryngeal cuff here is formed to be biocompatible with the laryngeal opening of the animal or human patient. And is shaped to form a substantially fluid tight seal with the patient's laryngeal opening, where the surface of the cuff is usually elongated and substantially oval, and the surface of the laryngeal cuff includes an opening, The opening of the laryngeal cuff at this point tapers or narrows towards the proximal end of the cuff.

  Preferably, the opening of the airway tube at the proximal end of the laryngeal cuff is substantially V-shaped and the narrowing of the V-shaped opening means that the patient's epiglottis is distal of the airway tube during use Acts as a rest of the epiglottis to prevent blocking the end.

  Preferably, the ratio A / B of the length A of the major axis of the ellipse to the length B of the minor axis of the ellipse is more than 2 ± 10%, more preferably 2.3 ± 10%, still more preferably 2 .5 ± 10% larger.

  In a particularly preferred embodiment, the ratio A / B is 2.6 ± 10%.

  Preferably, the surface of the cuff is substantially oval in shape, but the shape of the openings in the surface of the cuff is non-elliptic.

  Preferably, the width of the opening at the proximal end of the surface of the cuff is narrower than the width of the opening at the distal end of the airway cuff.

  Preferably, the laryngeal cuff surface incorporates the rest of the epiglottis and retains the epiglottis so as to substantially avoid the openings in the surface of the laryngeal cuff, so that the epiglottis of the patient in use is the opening of the distal end of the airway tube The size, shape and position are set to prevent blocking.

  Preferably, the airway tube has a height H and a width W, and the epiglottis support here comprises a cuff or a region of the airway tube that stands or protrudes above the usual height H of the contour of the airway tube Do.

  Preferably, the narrow area of the opening on the surface of the cuff corresponds to the area of the rest of the epiglottis. In one embodiment, the narrowed area of the opening on the surface of the cuff serves as a rest of the epiglottis.

  Preferably, the main plane of the surface of the laryngeal cuff is at an angle between 10 degrees and 40 ± 5 degrees with respect to the main longitudinal axis of the airway tube, and more preferably, the main longitudinal axis of the surface of the cuff and the airway tube The angle between is between 15 degrees and 25 ± 5 degrees. Preferably, the surface of the laryngeal cuff is made of a material having a Shore hardness of A scale of 60 or less, preferably 40 or less, and more preferably, the surface of the laryngeal cuff is A scale between 000 and 20 Made of a material having a Shore hardness of It can be seen that during use only the surface of the cuff directly contacts the patient's larynx. As such, the surface of the cuff may be made of a different material, usually softer than the rest of the body of the cuff. In areas where different materials are used, this may be in the form of an overlay or cover of softer material.

  In a particularly preferred embodiment, the airway tube and laryngeal cuff are made of a material having a Shore hardness of A scale of 60 or less, and more preferably, the airway tube and laryngeal cuff have a Shore hardness of A scale of 40 or less And more preferably 30 ± 10.

  In another preferred embodiment, the airway tube and laryngeal cuff are made of a material having a Shore A hardness of 20 or less.

  Preferably, the device further comprises an oral stabilizer, said oral stabilizer being adapted to rest on the front or front of the patient's tongue, and configured to correspond to the details of that part of the patient, whereby the airway during use is used. It provides stability by preventing tube rotation or left / right motion.

  Preferably, the softness of the laryngeal cuff is adapted by forming a cavity or groove in the body itself of the cuff.

  Preferably, the surface of the laryngeal cuff and the frontal ventral portion of the oral stabilizer are made of a material of substantially the same Shore hardness.

  Preferably, the oral stabilizer is at a first ventral surface substantially in the same plane as the plane of the airway tube.

  Preferably, the oral stabilizer extends from the proximal end of the laryngeal cuff towards the proximal end of the airway tube such that the cuff and oral stabilizer are of unitary construction.

  Preferably, the oral stabilizer is not uniform in its width W and has a wide point located midway between the laryngeal cuff and the proximal end of the airway tube, and preferably the wide point of the oral stabilizer is the airway tube Closer to the laryngeal cuff with respect to the proximal end of the.

  Preferably, the ratio to the height H of the oral stabilizer at the same point as the width W of the oral stabilizer at its widest point is 2.7 ± 20%.

  Preferably, the surface of the oral stabilizer in contact with the patient's tongue is roughened during use due to the increased friction between the tongue and the stabilizer.

  Preferably, the oral stabilizer is formed as an integral part of the airway tube, and more preferably, the oral stabilizer, airway tube and laryngeal cuff area are made as an integral unit.

  Preferably, the oral stabilizer is non-distensible.

  In another embodiment, the oral stabilizer is expandable.

  Preferably, the device further comprises a gastric tube channel extending from the cuff of the cuff to the proximal end of the device, and preferably the gastric tube channel is housed within the device body.

  Preferably, the gastric tract extends along the airway, and more preferably, the gastric tract continues from the opening at the proximal end of the device to the opening at the distal tip of the laryngeal cuff.

  Preferably, the epiglottis support further comprises a leaf-like structure extending away from the laryngeal cuff.

  Preferably, the surface of the laryngeal cuff further comprises one or more feather-like prongs.

  Preferably, the distal tip of the device is sized and shaped to create an esophageal obstruction, substantially closing a fluid seal therein to block the opening to the subject's esophagus during use. By increasing the length of A, or the long axis of the substantially oval cuff, the distal tip of the cuff is designed to reach or partially into the subject's esophagus It can be done. The distal tip volume may be configured to occlude the subject's esophagus during use.

  As such, the distal tip of the device is preferably made as a wide extension to the normally elongated substantially elliptical surface of the laryngeal cuff. This is one reason why the shape of the laryngeal cuff deviates from a true ellipse.

  Preferably, the back or back surface of the laryngeal cuff includes one or more ridges, which are sized and shaped so that they contact the back of the subject's throat during use ing. This serves to hold the device on the laryngeal opening by including a raised area behind the cuff that contacts the structure opposite the laryngeal opening of the subject during use, and 2 Create a gentle force that improves the seal between the two.

  Preferably, the ridges are in the form of a soft, raised cushion. The raised area is preferably behind the proximal portion of the opening on the surface of the cuff.

  In a further preferred embodiment, the ventral portion of the front of the cuff may be inflatable. Expandable laryngeal cuffs are known per se, but not with regard to the particular shapes and contours described herein. The inflatable cuff on the front of the laryngeal cuff may be used with or without the inflatable back cuff or cushion. This choice is made, in part, depending on which animal the particular device is intended to be used.

  The present invention relates to a method of manufacturing an airway device of the type claimed herein.

  The manufacturing method includes shaping the airway tube, the laryngeal cuff and the epiglottis support, and the oral stabilizer, if any, around the connection adapted to connect to the anesthetic gas delivery unit.

  Two injection molding processes may be used when different parts of the device are made of different plastic materials or plastic materials of different Shore hardness. In addition, insert molding techniques may also be used. In the case of thermosetting crosslinkable materials, molding techniques such as compression molding may be used. Liquid silicone rubber and solid silicone rubber materials require special molding techniques that depend on the particular plastic material used.

  Alternatively, the internal airway and connections may be made in the first stage, and the remaining portion of the device at its peripheral portion may be shaped in the second stage.

  In a further option, the inner airway tube and connections extend to the back plate of the cuff providing support for the airway conduit and a portion of the cuff at the first stage, a sleeve of the same Shore hardness as the spine or spine The rest of the device may be molded around the part in a second step, using a soft material having a Shore hardness of from 000 to 20 ± 5.

  In a further process, the laryngeal cuff, the support of the epiglottis and the outer part of the airway tube may be shaped as a single part and, if present, may include an oral stabilizer. This portion is then pierced through the portion of the pre-formed connection, which may or may not include the internal airway tract and bite protection.

According to a further aspect of the invention, there is provided a method of anesthetizing an animal or human subject using a laryngeal device as required comprising the following steps.
(I) Providing a laryngeal airway device as claimed herein.
(Ii) plugging the device into the subject such that it forms a substantially fluid-tight and air-tight seal at the subject's laryngeal opening;
(Iii) applying an anesthetic gas to the subject through the device.

  The invention will now be described, by way of example only, with reference to the accompanying drawings.

FIG. 1 is a front anisometric view of the first embodiment of the invention in the separated state. FIG. 2 is a back-anisometric view of the first embodiment of the invention in the separated state. FIG. 3 is a front anisometric view of the embodiment shown in FIG. 1 in an assembled condition. FIG. 4 is a front anisometric view of the embodiment shown in FIG. 2 in the assembled condition. FIG. 5 is a rear view of the embodiment in the assembled condition shown in FIGS. 3 and 4; FIG. 6 is a front view of the assembled embodiment shown in FIGS. 3 and 4; FIG. 7 is a side view of the embodiment in the assembled state shown in FIGS. 3 and 4; FIG. 8 is a cross-sectional view of the embodiment in the assembled state shown in FIGS. 3 and 4; FIG. 9 is an end view of the assembled embodiment shown in FIGS. 3 and 4; FIG. 10 illustrates a view of a further embodiment, with the connection removed, including a ridge along the airway and an inflatable cuff. FIG. 11 illustrates a view of a further embodiment, with the connection removed, including a ridge along the airway and an inflatable cuff. FIG. 12 illustrates a view of a further embodiment, with the connection removed, including a ridge along the airway and an inflatable cuff. FIG. 13 illustrates a view of a further embodiment, with the connection removed, including a ridge along the airway and an inflatable cuff. FIG. 14 illustrates a view of a further embodiment, with the connection removed, including a ridge along the airway and an inflatable cuff. FIG. 15 illustrates a view of a further embodiment, with the connection removed, including a ridge along the airway and an inflatable cuff. FIG. 15A illustrates a view of a further embodiment, with the connection removed, including a ridge along the airway and an inflatable cuff. FIG. 16 illustrates a diagram of a further embodiment. FIG. 17 illustrates a diagram of a further embodiment. FIG. 18 illustrates a diagram of a further embodiment. FIG. 19 illustrates a diagram of a further embodiment. FIG. 20 illustrates a diagram of a further embodiment. FIG. 21 illustrates a view of an embodiment including a gastric tube passageway. FIG. 22 illustrates a view of an embodiment including a gastric tube passageway. FIG. 23 illustrates a view of an embodiment including a gastric tube passageway. FIG. 24 illustrates a view of an embodiment including a gastric tube passageway. FIG. 25 is a perspective view of a further embodiment suitable for larger animals. FIG. 26 is an exploded view of the inflatable cuff assembly on the back of the device shown in FIG. 25. FIG. 27 is a rear view of the device of FIG. FIG. 28 is a front view of the device of FIG. FIG. 29 is a side view of the device of FIG. FIG. 30 is a cross-sectional view taken along the line C-C in FIG. 31 is a cross-sectional view taken along the line B-B in FIG. FIG. 32 is an end view of the device of FIG.

  Embodiments of the invention are described below by way of example only. These examples show the best way to put the invention into practice, but they are not the only ways in which this can be achieved.

  Referring to FIG. 1, it shows a laryngeal mask airway device 10 according to a first embodiment of the invention in the disassembled state. It comprises an airway tube 11, the proximal end 12 of which terminates at 15 mm or at another connection 15 suitable for connection to a conventional anesthesia breathing apparatus. A laryngeal cuff or cup 14 adapted to a shape and contour corresponding to the laryngeal area of the patient is formed around the distal end 13 of the airway tube. In this context, the terms cuff and cup have the same meaning. They show the elements of the device at the distal end of the airway tube that are adapted to cover and form a seal with the patient's larynx during use of the device.

  It can be seen in Figures 1 to 9 that the laryngeal cuff smoothly assimilates into the airway tube body. There is no clear demarcation line between the cuff area and the airway tube in this embodiment because of the smooth transition between the cuff and the airway tube. As such, the term "cuff region" is defined as that portion of the device beyond the oral stabilizer region 22 towards the distal end of the device. It is also understood that the ventral portion of the cuff region includes the cuff surface. The cuff surface is the area that, in use, interacts with the subject's larynx. The characteristics of the cuff surface are described in more detail below.

  The cuff area includes the anterior abdominal area and the posterior dorsal area. It can be seen that there is usually no clear boundary between these two parts, especially when both the abdominal part and the back part are formed from the same material, i.e. from the same Shore hardness material. For example, as in item 30 of FIG. 2, there may be a boundary between the abdominal and back portions. This boundary is particularly pronounced when the front of the laryngeal cuff 31A is formed from a first material of Shore hardness different from the rest of the cuff and the airway tube and oral stabilizer 31B. Generally, the surface of the laryngeal cuff 31A is formed of a first material which is softer than the cuff formed of the second material and the remainder of the airway tube 31B.

  Regions of different Shore hardness can also be understood from FIG.

  As a typical Shore hardness, the first material occupying the surface of the cuff usually has a Shore hardness of 20 or less, more preferably 15 or less on A scale. A particularly preferred Shore hardness range is one which includes 000 to 10 on A scale. 000 or triple zero includes materials that can not be measured on the A scale, because the hardness or more particularly the softness is too soft.

  The second, harder material that makes up the cuff and the back portion or back of the airway tube is typically formed of a material having an A scale Shore hardness of 60 or less, preferably 50 or less. A particularly preferred hardness range is 20 to 40.

  Plastic articles composed of plastics with two different hardnesses are known, and two injection molding processes are used for their production.

  The abdominal portion includes the cuff surface and also an airway opening leading to the airway. It is the form of the cuff surface in these various embodiments that imparts several important properties to the airway device according to the present invention. In the context of this description, the term "proximal" means the end of the device or a portion thereof closest to the connection to the anesthesia breathing system. The term "distal" means the end of the device or portions thereof that are the farthest from the anesthetic respiratory system in use.

The laryngeal cuff 14 is non-distensible in this example. Non-inflatable cuffs themselves are disclosed, for example, in British Patent GB 2,383,399. This particular cuff incorporates features designed to prevent the epiglottis of an animal or human subject from blocking the airway opening 17 at the surface of the laryngeal cuff. The first of these features is the epiglottis support 16. This structure is located at the proximal end of the abdominal portion of the cuff, is above the normal contour of the airway tube and is a protrusion. This can be more clearly understood from the cross-sectional view of FIG. 8 where it begins to assimilate with the cuff from the connection 15. The normal height of the airway tube is shown as H. The height of the epiglottis support above this normal height H is designated as H ¹ . Thus, the support of the epiglottis may protrude from the normal main longitudinal contour of the airway tube by an amount of H ± 100% H, preferably an amount of H ± 50% H, more preferably an amount of H ± 25% H . This shows a protrusion that is much greater than the height found in airway devices with any of the previous non-distensible cuffs. Therefore, preferably H ¹ equals H ± 100% H, more preferably H ¹ equals H ± 25% H.

In view of the height of the support of the epiglottis, the overall height of the apparatus in the region of the epiglottis support is defined as H + H ^1. H + ^{H 1} is normal height of the airway tube, that is, when expressed as a ratio of greater than H, the ^{ratio, (H + H 1) /} H , in a preferred embodiment, equal to between 1.5 and 3, more preferably Is equal to between 1.7 and 2.5.

  The epiglottis support 16 extends towards the distal tip of the device and is fused to the cuff surface. This can be seen from Figures 1, 3 and 6.

  The structure of the epiglottis support can have many forms and include many features. It may include, for example, a wing-shaped epiglottis lip or lip 18. The lip extends upwardly and rearwardly away from the cuff opening and towards the proximal end of the device. The lip is anatomically based on the epiglottis to support the back of the epiglottis and to ensure a favorable seal, so as not to bend towards the larynx, ie not to impede the flow of air It is set in size and shape. The lip is in the form of a leaf-like structure that extends out of the laryngeal cuff and is directed posteriorly towards the proximal end of the airway tube. Its relative size and shape can be seen from Figures 1, 3, 7 and 8. Its optimal size and shape may be determined by experimentation and may depend on the species of animal that the airway device is intended for.

  While this lip is shown as a straight leaf-like structure in this example, the other shape keeps the patient's epiglottis from blocking the airway opening on the cuff surface during use, with similar desirable effects It can be seen that it can have

  FIG. 1 also shows a further design feature, namely a narrow, flexible wing-like rim 19 extending around the proximal part of the cuff opening.

The tongue 19 is preferably formed as an integral part of the cast of the cuff, as shown more clearly in FIG. And because of the very soft nature of the material used to form the cuff, this prong is particularly soft and pliable. Its purpose is to weigh any individual patient's differences in the shape of the larynx, and to contribute to forming an efficient and effective seal between the cuff and the laryngeal structure. With this design, and by designing an anatomically based cuff, the sealing pressure obtainable from experimental trials is well above 30 cm H ₂ O.

  It will be appreciated that while only one lug is shown in FIG. 1, more than one lug may be provided. Such plurality of lugs are arranged in a concentric manner and radially spaced apart from one another. Furthermore, the extent to which these ridges extend around the circumference of the laryngeal cuff may be varied and does not necessarily have to be as shown in FIG.

  A further feature designed to prevent the subject's epiglottis from blocking the airway opening on the laryngeal cuff surface is the raised narrow area at the proximal end of the cuff surface shown at 20 and 21 in FIG. . The surface of conventional laryngeal cuffs, whether distensible or non-distensible, is wide oval and is slightly tapered towards the distal lip of the cuff. In the present invention, a completely new shape for the laryngeal cuff surface is formed. The outer contour of the surface of the cuff itself is substantially an elongated oval. As shown in FIG. 6, if the major axis length of the ellipse is defined as A, and the minor axis length of the ellipse is defined as B, then the ratio of A: B is 2 ± Greater than 10%. The ratio of A: B is preferably greater than 2.3 ± 10%, and more preferably about 2.5 ± 10%. The ratio of A: B in a particularly preferred embodiment is 2.6 ± 10%.

  However, the shape of the openings in this elongated elliptical cuff surface is not uniform along the major axis A. The size of the opening tapers or narrows towards the proximal end of the cuff such that the opening is V-shaped in the area of the support of the epiglottis. In this embodiment, this narrowing is created by the two opposing bulges 20 and 21 and these bulges are also raised substantially above the normal contour of the airway tube. The opening in this narrowed area is so narrow that it does not allow the subject's epiglottis to fall into the airway duct opening, and this narrowing, in combination with the raised epiglottis support, It ensures that the tube is always open. The subject's epiglottis may lie, in use, partially over the laryngeal cuff surface, while the elongated shape of the cuff surface and the narrowed opening of the cuff surface towards its proximal end All of these, and the support of the raised epiglottis, help secure the airway and help prevent obstruction by the patient's epiglottis.

  The angle formed between the two legs of “V” in the example shown in FIGS. 1 to 8 is approximately 30 ± 5 degrees. However, this angle is not the only angle that can be used. Suitable angles include angles between 50 ± 5 degrees and 10 ± 3 degrees.

  It will also be appreciated that the internal contours of the bulges 20, 21 forming this so-called "V" shape need not be straight. Thus, the legs of any "V" need not be straight. For example, the V-shape may tend to flare out as it flares towards the distal tip of the cuff.

  In addition, narrowing the opening of the cuff surface towards the proximal end of the cuff, which acts as a support for the epiglottis, does not have to reach individual points as with the conventional "V" shaped bottom. The shape of the opening at the proximal end or base of the cuff may be curved, flat or planar. Importantly, the opening in the area is narrow enough to prevent the patient's epiglottis from falling into the cavity in the cuff and blocking the end of the airway. This manifests itself clearly by the area of up to 50% of the length of the opening of the cuff surface having a width of the opening which is less than 50% of the width at the widest point of the width of the opening of the cuff surface There is. A preferred parameter is 30% of the length of the opening of the cuff surface having a width of the opening which is less than 40% of the width at the widest point of the width of the opening of the cuff surface.

  It will be appreciated that the narrowing feature of the V-shaped opening on the laryngeal cuff surface can be used independently of the other epiglottis support features. Alternatively, the features of the V-shaped opening may be completely eliminated, in which case the epiglottis support will take a different form.

  While all of the features described above are useful, they may be selected by the designer and taken separately and independently into the airway device and are not necessarily required to be present to produce the desired effect. Therefore, it turns out that everything is not an essential element. One feature does not depend on another for their effect. Thus, for example, a narrow V-shaped opening at the proximal end of the cuff surface opening may be used without a raised epiglottis support, if desired. And, as shown in FIGS. 16-24, an elongated oval cuff may be used without a V-shaped opening.

  The airway device shown in the figure also includes an oral stabilizer 22,122. Also known as pharyngeal stabilizer. Such a stabilizer is described in detail in British Patent GB 2,393,399, which is incorporated herein by reference in its entirety and is an integral part of this disclosure. In this example, the stabilizer is in the form of a symmetrically extended and expanded area on either side of the airway tube. The stabilizer is adapted to rest on the front or front of the tongue and is configured to correspond to the details of that part of the patient.

  The stabilizer can be of many different shapes, sizes and positions. The surface of the stabilizer is roughened, cut and roughened to increase friction with the tongue and thereby to stabilize it during use and prevent or reduce back and forth movement during use. It may be done.

  In this example, the stabilizer is integrally formed with the cuff so that one is stuck into the other smoothly. However, this is not essential and the stabilizer may be another unit on the airway tube. The essential feature of the stabilizer is that it is a wider area in cross section than the diameter of the airway tube itself. That is, it spreads in the same major plane as the laryngeal cuff, in the bilateral area of the airway.

  The stabilizer may be formed from an expanded portion with some desired flexibility around the airway tube wall located in front of the tongue. The body is primarily located along the longitudinal axis of the airway, and any suitably formed laterally extending ridges serve this purpose. The tongues need not be solid, so tubular, mesh or other perforated structures are acceptable.

  Such "slip" may be formed by broadening the contour of the airway tube in the appropriate area just above the cuff. That is, the oral stabilizer may be an integral part of the airway tube rather than being a separate part formed on or around the airway tube itself. Thus, regardless of whether it is formed by the tube itself or by forming additional material around the tube, proper expansion in the normal contour of the airway tube acts as a stabilizer.

  The usual contour of the oral stabilizer and the manner in which it assimilates smoothly into the cuff area can be seen in more detail from FIGS.

It will be appreciated that while an oral stabilizer is a preferred feature in such an airway device, it is not an essential feature.

  The connection 15 in this example consists of a connection 33 of the distal tubular part that fits snugly inside the airway tube 11 and a proximal part 32 of the connection designed to connect to the anesthetic gas supply device Be done. Portion 33 also acts as a bite protector and prevents the patient's teeth from drilling into the airway tract. Portion 33 also prevents airway obstruction when the subject must bite the airway tube.

  Figures 10 to 15 illustrate airway tubes and cuffs other than the connection of a further embodiment in which the cuff is inflatable. This embodiment also includes a series of ridges on the outer surface of the airway tube at or near the proximal end of the tube, which will be described in more detail below.

  When the inflatable tube 132 is equipped, it is preferably inside or alongside the airway, a portion of its length extending into the interior of the device and into the inflatable area of the cuff 113. The proximal end of the inflatable tube 132 includes a one-way valve mount 130 suitable for connection to a syringe body. This allows air to be introduced into the inflatable cuff via the syringe. Small balloons 131 in the inflatable tube provide the operator with a visual indication of the degree of cuff inflation.

  Techniques for producing inflatable cuffs are well known. The expandable region within the cuff is formed during the molding or manufacturing process and is connected to the expandable tube 132.

  A connection, such as shown as 15 in FIG. 1, is inserted into the end of airway tube 111 to complete the airway device.

  A series of ridges 135, 136, 137 and 138 are provided, the ridges along the outside of the airway tube being spaced from one another along the longitudinal axis at the proximal end of the device. Most animals are covered with hair which, during use, makes it difficult or impossible to tape the airway device tightly to the animal's head. Instead, these devices may be tied to the animal's head and these ridges help this tying process.

  The features of the interconnection between the connection and the device body are shown in FIG. In this example, the connection portion 15 is also incorporated in part of the airway tube 33. This fits into the softer airway tube 11 of the device, and in doing so provides additional hardness where the airway device is made of a very soft plastic material.

  From the point of view of the preferred material, in one preferred embodiment, the cuff is non-distensible and is formed of any suitable soft plastic material. As a preferred range of softness (hardness), a hardness less than 60 of shear hardness A scale is optimum for the cuff surface in contact with the larynx.

  As a preferred range, values of the same scale between 000 and 40 are preferred, in particular in the range of 000 to 12. The flexibility of the cuff may be further adapted by forming a cavity or groove in the body of the cuff itself.

  Referring to the cross section shown in FIG. 8, the connection 15 and the associated tube 33 are made of one plastic material and the rest of the device is made of a plastic material that is softer than another of the above mentioned Shore hardness You can see that. The preferred Shore hardness range for connections is about 80 on the A scale. Where the bite protection is included, the shear hardness may be greater than 80 to achieve the required strength and hardness.

  In the embodiments described so far, as in FIGS. 7, 8 and 11, the contour of the cuff surface when viewed from the side is not completely flat. Slight dents and bumps are provided to better fit the patient's laryngeal details. However, it has unexpectedly been found that these indentations are not essential and that an acceptable sealing pressure can be obtained with a device having a substantially flat cuff surface, as shown in FIG. 15A. . In this embodiment, the surface of the cuff 41 is substantially planar. The back or back of the cuff, as described above, includes a raised or raised area 40 on the back of the cuff that contacts, in use, the structure opposite the larynx. This feature provides an improved seal between the airway device and the subject's laryngeal opening. The bulge may be larger than that shown in FIG. 15A, depending in part on the details of the animal subject for which the airway device is designed. The ridges may be formed by the inflatable region at the back of the cuff, as illustrated in FIGS. 25-32 described below.

  The effectiveness of these planar devices can be enhanced by the incorporation of bulges or bumps on the back or back of the cuff. Such bulges push the back of the pharynx during use and improve the sealing contact between the cuff surface and the laryngeal opening.

  A further embodiment is shown in FIGS. 16-24. These further embodiments all share features with significant epiglottis support that protrude significantly from the normal contour of the airway tube, as seen in the side view. Due to this raised epiglottis rest, the surface of the laryngeal cuff has two angles to the longitudinal axis of the airway tube, for example slightly on the contour of the cuff surface when viewed in a side view as shown in FIG. It tends to be concave.

  Another feature shared by these embodiments is that the ratio A / B of the length of the major axis A of the ellipse of the cuff surface to the length of the minor axis B of the ellipse is at least about 2.0. is there. The method of calculating the ratio A / B is the same as the method described above.

  A numbering scheme similar to that used in FIGS. 1 to 8 is used in these figures.

  Similar to the elongated oval or substantially oval cuff surface, these embodiments include very clear epiglottis support, as shown in FIGS. 17 and 22.

  The distal tip 214 of the cuff is elongated and more elongated than known airway devices. This allows, in use, the tip of the cuff to extend into the subject's epiglottis and to block the epiglottis and form a significant fluid seal therein.

  The combination of the elongated oval on the cuff surface and the raised epiglottis support means that the V-shaped opening on the surface of the cuff is not necessary for the device to work effectively.

  The embodiment illustrated in FIGS. 21-24 includes a gastric tract. Such a passage itself is known from British Patent GB 2,393,399, which is incorporated herein by reference in its entirety and is an integral part of this disclosure. A gastric tract separate from the airway opens from the opening 340 of the connection to the opening 341 at the distal tip of the device and along the airway for most of its length. Alternatively, although not shown, the gastric duct may continue as a separate tube inside the airway as part of its length.

  Further embodiments of the invention are illustrated in FIGS. 25-32. FIG. 25 illustrates the dorsal perspective of the device. A numbering scheme similar to that used in Figures 1 to 8 is used in these figures. The device 410 is comprised of an airway tube 411, the proximal end of which is adapted to fit the type of connection shown as 15 in FIG. 1 or similar figures. A laryngeal cuff 414 is formed around the distal end of the airway tube. An oral stabilizer 422 is formed around the airway in the region between the laryngeal cuff 414 and the proximal end of the device. An oral stabilizer is a desirable feature while an option, not an essential feature, and it can be seen that such a device works without any oral stabilizer.

  In this example, the front of the laryngeal cuff 431A is formed from a first material of a first Shore hardness, and the remaining portion of the device 431B shown in FIGS. 25-32 is a back ridge as described below Or with the exception of the inflatable cuff, it is made of a second material of a second Shore hardness. The first and second materials are different and preferably have different Shore hardnesses. However, this too is not essential, and the entire device, except for the connections (not shown), may be made of a single material. The conventional Shore hardness for the first and second materials, where two different materials are used, is similar to that described above with respect to the embodiments shown in FIGS.

  A further feature of the current embodiment is the inflatable back cuff or ridge 440, the structure of which is shown in more detail in FIG. This cuff consists of an inflatable tube 432, a fairly or relatively stiff back plate and a frame 451 and a resiliently deformable soft backing cushion, around the periphery of the back cushion in a substantially liquid-tight manner Sealed to the back plate and frame, thereby creating an inflatable cavity or cuff. The introduction of air or some other fluid through the inflatable tube 432 causes the back cushion to spread apart from the cuff body. The inflatable tube check valve allows the cuff to hold a predetermined inflation or a predetermined contraction.

  Once assembled, a portion of the inflatable tube 432 is housed in the body of the device at the proximal end of the airway of the body through the opening 454 as shown in FIG.

  With regard to the method of manufacture, the assembly of the inflatable back cuff can be made as one unit and adapted to the correspondingly shaped cavity at the back of the device, the inflatable tube 432 being provided with an inner Through a hole in the hole 454 so as to thread through. Alternatively, the remainder of the device may be molded around the preformed back cuff in one or two molding steps required.

  The surface of the laryngeal cuff in this embodiment is shown in FIG. 1 from the narrow V-shaped openings 420, 421 at the proximal end of the cuff, the raised epiglottis supports 416, 418 and the elongated oval cuff plane. The features of the embodiment shown in FIG.

  The use of inflatable back cuffs has improved sealability in certain animal species such as large livestock such as dogs, larger animals such as horses, and in some humans, particularly children. give.

  In summary, a new type of airway device was designed to secure and maintain the patient's airway during normal or emergency anesthesia for surgery during spontaneous or intermittent positive pressure ventilation. It includes a non-inflatable or inflatable cuff made of a soft material. It is expected to cause less pressure trauma than other devices while in animal life. This design includes an oral stabilizer that aids in insertion and thereby reduces the likelihood of rotation and associated positional anomalies. In certain embodiments, the laryngeal cuff of the device is non-distensible, so as to provide a satisfactory seal for nausea in final production so as to be able to adapt to the individual details of the subject's laryngeal opening , Made of soft, deformable material.

  The cross section in the form of the oral stabilizer is widened, elliptical in the contour, symmetrical and laterally flattened in order to reflect the bottom of the tongue which gives good vertical stability upon insertion There is. The tube section is stiffer than the soft recess in the cuff of the device. The stiffness of the canal and its inherent oropharyngeal curvature allow the device to be inserted into the pharynx by sliding the leading edge against the hard palate and capturing the proximal end of the device . Early dissection studies did not require the insertion of a finger or laryngoscope into the subject's mouth to achieve complete insertion. The smooth shaped surface of the device, from the tip of the cuff's recess and across the entire airway tube, helps facilitate sliding the device along the hard palate, pharynx and hypopharynx towards the posterior end . The surface of the non-distensible laryngeal cuff is shaped to create an anatomically compatible one on the larynx port of a small animal patient. The beak-like face of the laryngeal recess incorporates the rest of the epiglottis. It is designed to prevent the subject's epiglottis from blocking the opening at the distal end of the airway tube during use by holding the epiglottis to substantially clear the opening on the surface of the laryngeal cuff There is.

Compared to the previous design, the design of the invention is:
The cuff portion of the device has been narrowed considerably to make a much more slim device in the lateral direction.
Inclusion of a gastric tube (to allow for aspiration of regurgitated material) similar to the i-gel (RTM) design is not always possible with very narrow cuff versions, especially for rabbit and cat designs I understand.
The outer wall of the laryngeal portion of the cuff is increased in thickness to provide greater deflection of the epiglottis away from the recess in the opening of the cuff.
The esophagus part of the device was narrowed, tapered and flared. This provided the directional stability on insertion of the device and the accompanying stability once set.
The oral part of the device was considerably shortened, taking into account differences in body size and head shape from pediatric situations.
Lateral pharyngeal stabilizers 20, 21 were made from gentle extension around the airway canal wall. These achieve greater resistance to rotation and provide considerable protection against epiglottis bending into the airways.
Small radial ridges were created in the proximal region of the tube, thereby providing increased friction to prevent the tube knot from slipping during general anesthesia. These changes make a very secure connection and allow the anesthesiologist to easily and safely wear the device.

  These devices are used in both animal and human applications, especially in pediatrics. While not wishing to be bound by any particular theory, these devices seal the soft tip of the device that forms the seal at the tip of the esophagus and the area closely surrounding the patient's larynx The formed cuff surface forms a seal.

Claims (85)

An airway device for animal and human use,
The device comprises an airway tube having a distal end and a proximal end;
The posterior end of the airway tube is surrounded by a laryngeal cuff,
The surface of the laryngeal cuff is shaped to conform to the laryngeal opening of the animal or human patient and to seal the laryngeal opening of the patient,
The surface of the laryngeal cuff is usually elongated and substantially oval in shape;
An airway device, wherein the ratio A / B of the major axis length A of the ellipse to the minor axis length B of the ellipse is greater than 2 ± 10%.   The airway device according to claim 1, wherein the ratio A / B is greater than 2.3 10%.   The airway device according to claim 1, wherein the ratio A / B is greater than 2.5 ± 10%.   The airway device according to claim 1, wherein the ratio A / B is 2.6 ± 10%.   The airway device according to any one of the preceding claims, wherein the surface of the cuff is substantially elliptical, but the shape of the openings in the surface of the cuff is non-elliptic.   6. The airway device of claim 5, wherein the width of the opening at the proximal end of the surface of the cuff is narrower than the width of the opening at the distal end of the airway cuff. The surface of the laryngeal cuff is
By holding the epiglottis so as to substantially avoid the opening at the end of the airway tube, and in use, the epiglottis of the patient is sized such that the opening at the distal end of the airway tube is not blocked. The epiglottis support in a position that is shaped and does not block the opening at the distal end,
The airway device according to any one of claims 1 to 6. The airway tube has a height H and a width W,
8. The airway device according to claim 7, wherein the epiglottis support / rest comprises an area of the cuff or airway tube that stands or protrudes above the normal height H of the contour of the airway tube.   8. The airway device as claimed in claim 7, wherein the narrow area of the opening in the surface of the cuff comprises the support of the epiglottis. The opening of the airway tube at the proximal end of the laryngeal cuff is substantially V-shaped;
10. The narrowed V-shaped opening functions as a epiglottis rest to prevent the distal end of the airway tube from blocking the patient's epiglottis during use An airway device according to item 1.   11. An airway according to any of the preceding claims, wherein the main plane of the surface of the laryngeal cuff is at an angle between 10 degrees and 40 ± 5 degrees with respect to the main longitudinal axis of the airway tube. apparatus.   12. The airway device according to claim 11, wherein the angle between the surface of the cuff and the main longitudinal axis of the airway tube is between 15 degrees and 35 ± 5 degrees, preferably 30 ± 5 degrees.   13. An airway device according to any of the preceding claims, wherein the surface of the laryngeal cuff and the body of the laryngeal cuff and the airway tube are made of a material of substantially the same Shore hardness.   14. An airway device according to any of the preceding claims, wherein the surface of the laryngeal cuff is made of a first material having a Shore hardness of A scale of 20 or less, preferably 15 or less.   15. The airway device according to claim 14, wherein the surface of the laryngeal cuff is made of a first material having a Shore hardness of A to 1000 000.   The airway passage, the oral stabilizer, if any, and the back of the laryngeal cuff are made of a material having an A scale Shore hardness of 60 or less, preferably 50 or less. Airway device according to paragraph.   17. The airway device according to claim 16, wherein the airway tube, the oral stabilizer, if any, and the back of the laryngeal cuff are made of a material having an A scale Shore hardness in the range of 20 to 40. The airway device further comprises an oral stabilizer,
The oral stabilizer is adapted to stabilize on the front or face of the patient's tongue and is configured to correspond to the details of the portion of the patient, thereby preventing rotation or left-right movement of the airway tube in use 18. An airway device according to any of the preceding claims, which provides stability for   19. An airway device according to any of the preceding claims, wherein the softness of the laryngeal cuff is altered by forming a cavity or groove in the body of the cuff itself.   20. An airway device as claimed in claim 18 as claimed in claim 18 or claim 18 in which the surface of the laryngeal cuff and the ventral part in front of the oral stabilizer are made of a material of substantially the same Shore hardness. .   Claim 20 or Claim 19 or Claim 20 when dependent on Claim 18 or Claim 18 wherein the oral stabilizer has a first ventral surface in substantially the same plane as the plane of the airway tube. Airway device.   19. A subsidiary according to claim 18 or claim 18, wherein the oral stabilizer extends from the proximal end of the laryngeal cuff towards the proximal end of the airway tube, the cuff and the oral stabilizer being of unitary construction 22. An airway device according to any one of claims 19 to 21 in cases.   19. Subordinate to claim 18 or claim 18, wherein said oral stabilizer is not uniform in its width W and has wide points located midway between said laryngeal cuff and the proximal end of said airway tube An airway device according to any one of claims 19 to 22   24. The airway device of claim 23, wherein the broad point of the oral stabilizer is closer to the laryngeal cuff than the proximal end of the airway tube.   The ratio of the width W at the widest point of the oral stabilizer to the height H of the oral stabilizer at that point is between 2.0 and 3.0 ± 20%, preferably 2.5 to 2. 25. The airway device of claim 24, which is between 7 ± 20%.   Claim 18 or Claim 18 when depending on claim 18 or claim 18, wherein the surface of the oral stabilizer in contact with the patient's tongue is roughened to increase the friction between the tongue and the stabilizer during use. An airway device according to any one of the preceding claims.   27. An airway device according to any one of claims 19 to 26, as dependent on claim 18 or claim 18, wherein the oral stabilizer is formed as an integral part of the airway tube.   28. The airway device according to claim 27, wherein the area of the oral stabilizer, the airway tube and the laryngeal cuff are formed as an integral unit.   29. The airway device according to any one of claims 19 to 28, when dependent on claim 18 or claim 18, wherein the oral stabilizer is non-distensible.   29. The airway device according to any one of claims 19 to 28, when depending on claim 18 or claim 18, wherein the oral stabilizer is expandable.   31. The airway device of any of claims 19-30, wherein the device further comprises a gastric tube passageway extending from the tip of the cuff to the proximal end of the device.   32. The airway device of claim 31, wherein the gastric tube passageway is housed in the body of the device.   33. The airway device of claim 31 or 32, wherein the gastric tube passageway extends along the airway tube.   34. The airway device of any of claims 31-33, wherein the gastric tube passageway continues from the opening at the proximal end of the device to the opening at the distal tip of the laryngeal cuff.   35. The airway according to any one of claims 8 to 34 when dependent on claim 7 or claim 7 wherein the epiglottis support further comprises a leaf-like structure extending away from the laryngeal cuff. apparatus.   36. The airway device of any one of the preceding claims, wherein the laryngeal cuff further comprises one or more winged ridges.   The distal tip of the device is sized and shaped to create an esophageal occlusion organ, and in use, the opening to the esophagus of the subject is closed by creating a fluid seal therein. 37. An airway device according to any one of the preceding claims.   40. The airway device of claim 37, wherein the distal tip of the device is formed as a wide extension on the generally elongated, substantially elliptical surface of the laryngeal cuff. The posterior or posterior surface of the laryngeal cuff comprises one or more ridges,
39. The airway device of any of the preceding claims, wherein the ridges are sized and shaped to contact the back of the subject's throat during use.   40. The airway device of claim 39, wherein the ridges have the form of a soft raised cushion or an inflatable back cuff.   41. The airway device of claim 39 or 40, wherein the ridge is located opposite the proximal portion of the opening in the cuff surface. An airway device for animal and human use,
The airway device comprises an airway tube having a distal end and a proximal end,
The distal end of the airway tube is surrounded by a laryngeal cuff,
The surface of the laryngeal cuff is shaped to anatomically conform to the laryngeal opening of the animal or human patient and to seal the laryngeal opening of the patient;
The surface of the cuff is usually elongated and substantially oval in shape,
The plane of the laryngeal cuff comprises an opening,
The airway device wherein the opening of the laryngeal cuff narrows and tapers towards the proximal end of the cuff. The opening of the airway tube at the proximal end of the laryngeal cuff is substantially V-shaped;
There is the narrowest part of the V towards the proximal end of the opening of the cuff surface,
43. The airway device of claim 42, wherein the narrowing of the V-shaped opening serves as a epiglottis rest to prevent the patient's epiglottis from blocking the distal end of the airway tube during use.   44. An airway device according to claim 42 or 43, wherein the ratio A / B of the major axis length of the ellipse to the minor axis length of the ellipse is greater than 1.5.   45. The airway device of claim 44, wherein the ratio A / B is greater than 2 ± 10%.   46. The airway device of claim 44 or 45, wherein the ratio A / B is greater than 2.5 ± 10%.   47. The airway device of any one of claims 44 to 46, wherein the ratio A / B is 2.6 ± 10%.   48. The airway device of any of claims 42-47, wherein the surface of the cuff is substantially elliptical in shape, but the shape of the openings in the surface of the cuff is non-elliptic.   50. The airway device of claim 48, wherein the width of the opening at the proximal end of the surface of the cuff is less than the width of the opening at the posterior end of the airway cuff. The surface of the laryngeal cuff includes the support of the epiglottis and, in use, is sized, shaped and positioned to prevent the patient's epiglottis from blocking the posterior opening of the airway tube,
50. The airway device of any of claims 42-49, wherein the epiglottis is held to substantially avoid the end opening of the airway tube. The airway tube has a height H and a width W,
51. The airway device according to claim 50, wherein the epiglottis support comprises an area of the cuff or airway tube that stands or protrudes above the normal height H of the contour of the airway tube.   51. The airway device of claim 50 as depending on claim 49, wherein the narrow area of the opening on the surface of the cuff comprises the support of the epiglottis.   53. The airway according to any one of claims 42 to 52, wherein the main plane of the surface of the laryngeal cuff is at an angle between 10 degrees and 40 ± 5 degrees with respect to the main longitudinal axis of the airway tube. apparatus.   54. The airway device according to claim 53, wherein the angle between the surface of the cuff and the main longitudinal axis of the airway tube is between 15 degrees and 25 ± 5 degrees, preferably 30 ± 5 degrees.   55. The airway device of any of claims 40 to 54, wherein the surface of the laryngeal cuff and the body of the laryngeal cuff and the airway tube are made of substantially the same Shore hardness material.   56. The airway device of any of claims 40 to 55, wherein the surface of the laryngeal cuff is made of a first material having a Shore hardness of A scale of 20 or less, preferably 15 or less.   57. The airway device of claim 56, wherein the surface of the laryngeal cuff is made of a first material having a Shore hardness of A to 1000 A scale.   58. Any one of claims 40 to 57 wherein the airway tube, the oral stabilizer, if any, and the back of the laryngeal cuff are made of a material having an A scale Shore hardness of 60 or less, preferably 50 or less. Airway device according to paragraph.   59. The airway device of claim 58, wherein the airway tube, the oral stabilizer, if any, and the back of the laryngeal cuff are made of a material having an A scale Shore hardness in the range of 20-40. The airway device further comprises an oral stabilizer,
The oral stabilizer is adapted to stabilize on the front or face of the patient's tongue and is configured to correspond to the details of the portion of the patient, thereby preventing rotation or left-right movement of the airway tube in use 60. The airway device of any one of claims 42-59, which provides stability for.   61. The airway device of any of claims 42 to 60, wherein the flexibility of the laryngeal cuff is altered by forming a cavity or groove in the body of the cuff itself.   61. An airway device as claimed in claim 60 as claimed in claim 60 or claim 60 in which the surface of the laryngeal cuff and the ventral portion in front of the oral stabilizer are made of a material of substantially the same Shore hardness. .   Claim 60 or claim 62 if dependent upon claim 60 or claim 60, wherein the oral stabilizer has a first ventral surface in substantially the same plane as the plane of the airway tube. Airway device.   61. Subordinate to claim 60 or 60, wherein the oral stabilizer extends from the proximal end of the laryngeal cuff towards the proximal end of the airway tube, the cuff and the oral stabilizer being in one piece. 64. An airway device according to any one of the claims 61-63.   61. If dependent on claim 60 or claim 60, wherein the oral stabilizer is not uniform in its width W but has a wide point located midway between the laryngeal cuff and the proximal end of the airway tube 64. An airway device according to any of claims 61-63.   66. The airway device of claim 65, wherein the broad point of the oral stabilizer is closer to the laryngeal cuff than the proximal end of the airway tube.   The ratio of the width W at the widest point of the oral stabilizer to the height H of the oral stabilizer at that same point is between 2.0 and 3.0 ± 20%, preferably 2.7 ± 20. 67. The airway device of claim 66, wherein the airway device is   Claim 60 to claim 60 as claimed in the case of claims 60 or 60 when the surface of the oral stabilizer in contact with the patient's tongue is roughened to increase the friction between the tongue and the stabilizer during use The airway device according to any one of clauses 67.   69. An airway device as claimed in any of claims 61 to 68 as depending on claim 60 or claim 60 wherein the oral stabilizer is formed as an integral part of the airway tube.   70. The airway device according to claim 69, wherein the region of the oral stabilizer, the airway tube and the laryngeal cuff are formed as an integral unit.   71. An airway device according to any of claims 61 to 70 dependent on claim 60 or claim 60, wherein the oral stabilizer is non-distensible.   71. An airway device as claimed in any of claims 61 to 70 when depending on claim 60 or claim 60 wherein said oral stabilizer is expandable.   73. The airway device of any of claims 42-72, wherein the device further comprises a gastric tube passageway extending from the tip of the cuff to the proximal end of the device.   74. The airway device of claim 73, wherein the gastric tube passageway is housed in the body of the device.   75. The airway device of claim 73 or 74, wherein the gastric tube passageway extends along the airway tube.   76. The airway device of any one of claims 73 to 75, wherein the gastric tube passage continues from the opening at the proximal end of the device to the opening at the distal tip of the laryngeal cuff.   78. The airway device of any of claims 51 to 76 as depending on claim 50 or claim 50, wherein the epiglottis support further comprises a leaf-like structure extending away from the laryngeal cuff.   78. The airway device of any of claims 42-77, wherein the laryngeal cuff further comprises one or more wing-like tangs.   The distal tip of the device is sized and shaped to create an esophageal obstruction, and in use, the opening to the esophagus of the subject is closed by creating a fluid seal therein An airway device according to any of the claims 42-78.   80. The airway device of claim 79, wherein the distal tip of the device is formed as a wide extension on the generally elongated, substantially elliptical surface of the laryngeal cuff. The dorsal or posterior surface of the laryngeal cuff comprises one or more ridges,
80. The airway device of any of claims 42-79, wherein the ridges are sized and shaped to contact the back of the subject's throat during use.   82. The airway device of claim 81, wherein the ridges have the form of a soft raised cushion.   83. The airway device of claim 81 or 82, wherein the dorsal ridge is expandable.   84. The airway device of any of the preceding claims, wherein the ventral portion of the front of the laryngeal cuff is inflatable. An airway device substantially the same as described with reference to the accompanying drawings herein.

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